Product Classification

• Device: orthosis, spinal pedicle fixation, for degenerative disc disease
• Regulation Description: Pedicle screw spinal system.
• Definition: Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at l5-s1 or degenerative spondylolisthesis with objective evidence of neurologic impairment.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: NKB
• Submission Type: 510(k)
• Regulation Number: 888.3070
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ASTM F2193-02(2007) Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
• ASTM F 983-86 (Reapproved 2009) Standard Practice for Permanent Marking of Orthopaedic Implant Components
• ASTM F 565-04 (Reapproved 2009)e1 Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• ASTM F1717-12 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
• ASTM F 2026-10 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
• ASTM F2024-10 Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings

Guidance Document

• Spinal System 510(k)s - Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible